Hyrimoz Sandoz’s biosimilar got European marketing approval
Posted on31 Jul 2018
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Sandoz, a Novartis division and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) granted marketing authorization... Read More
BMS Opdivo+Yervoy combo received USFDA new indication approval.
Posted on15 Jul 2018
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Bristol-Myers Squibb Company announced that its Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) has received... Read More
Amgen & UCB ‘s Romosozumab: Development Pathway and approval status
Amgen and UCB, a global biopharmaceutical company, announced the resubmission of the Biologics License Application (BLA) to the US Food and Drug... Read More
Medical Science Liaison (MSL) – A Career Option for Healthcare Professionals !
What is The Medical Science Liaison (MSL)? The Medical Science Liaison (MSL) is a specific job related role within the healthcare industries, e.g.... Read More
Quick look into Roche’s Tecentriq US FDA priority review grant
USFDA has accepted the Roche’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq. (atezolizumab), in combination with Avastin (bevacizumab),... Read More
Natco launched a generic version of Teriflunomide tablets for the treatment of relapsing and remitting forms of multiple sclerosis in India
Natco Pharma launched a generic version of Teriflunomide for the treatment of relapsing and remitting forms of multiple sclerosis (RRMS), under its... Read More
What is Humane endpoint in clinical research?
A humane endpoint can be defined as the point at which pain and/or distress is terminated, minimized or reduced for an entity... Read More
What is the difference of primary endpoint and secondary endpoint?
Posted on14 Dec 2017
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The primary endpoint of a clinical trial is the endpoint for which subjects are randomized and for which the trial is powered.... Read More
What is the meaning of clinical endpoint in clinical research?
Posted on14 Dec 2017
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In a clinical research or trial, a clinical endpoint generally refers to occurrence of a disease, symptom, sign or laboratory abnormality that... Read More
What is ISO IDMP standards? What it’s importance in drug regulation point of view?
IDMP stands for identification of medicinal products The European Medicines Agency (EMA) is in the process of implementing the standards developed by the... Read More